Our Process
Unlike any other global producer, the production of trū Chitosan is vertically integrated. We grow the shrimp, we harvest the exoskeleton tissue, we extract the chitin, and we deacetylate the chitin to your required specifications of DDA and Molecular Weight. We do not blend our lots of chitin or chitosan.
Your benefit? Unrivaled purity, consistent behavior, unimodal Mw distribution and a complete and detailed chain of custody for peace of mind. Whether in costly and time-consuming research, critical trials, or in full production of your pharmaceutical or medical device, why would you risk anything less than
trū Chitosan.
PACKAGE & DOCUMENT
The dried and ground tissue undergoes biological enumeration testing, lot assignment and chain-of-custody documentation before being packaged. Only then is it transferred to the reactions that yield trū Chitosan.
PRODUCE
The precisely SOP/GMP prepared and documented tissue is then run through a series of cGMP-governed reactions and drying steps in an FDA-registered and ISO 9001-certified facility to yield trū Chitosan.
ANALYZE
The finished lot of trū Chitosan is then analyzed using USP-NF specified procedures at both internal and external certified laboratories to ensure it meets the specifications of the USP-NF Monograph and appropriate USP 232 Limits for Impurities for Drug Delivery.
DOCUMENTATION & CREDENTIALS
With the analysis complete, a Certificate of Analysis and an industry-unique Certificate of Origin are issued documenting USP-NF and
USP 232 impurity level.
Let's talk chitosan.
Our experienced chitosan pros are here to provide detailed information and help assess your unique needs.
CULTIVATE
Consistent chitosan behavior begins with homogenous exoskeleton tissue. trū Chitosan's foundation is a single species of Pacific White Legged Shrimp (litopenaeus vannamei) producing identical exoskeleton tissue day-in and day-out. Shrimp and crab exoskeleton are the only recognized sources for USP-NF (United States Pharmacopeia-National Formulary) conforming chitosan.
COLLECT
We harvest exoskeletal tissue from the shrimp grown in our captive indoor Tidal Basin and immediately preserve it by drying it (<0.60 water activity) and prepare it for conversion by grinding to a precise particle size.